Application Sponsors
| ANDA 087552 | SUN PHARM INDUSTRIES | |
Marketing Status
Application Products
| 001 | TABLET;SUBLINGUAL | 1MG | 0 | ERGOLOID MESYLATES | ERGOLOID MESYLATES |
FDA Submissions
| ORIG | 1 | AP | 1981-08-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1983-11-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1985-12-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1985-12-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1985-12-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1987-03-31 | |
| LABELING; Labeling | SUPPL | 13 | AP | 1988-12-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1992-04-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1992-04-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1994-10-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1994-12-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1998-12-01 | |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
CDER Filings
SUN PHARM INDUSTRIES
cder:Array
(
[0] => Array
(
[ApplNo] => 87552
[companyName] => SUN PHARM INDUSTRIES
[docInserts] => ["",""]
[products] => [{"drugName":"ERGOLOID MESYLATES","activeIngredients":"ERGOLOID MESYLATES","strength":"1MG","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ERGOLOID MESYLATES","submission":"ERGOLOID MESYLATES","actionType":"1MG","submissionClassification":"TABLET;SUBLINGUAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)